2023-02-01| Trials & Approvals

Amgen’s Humira Biosimilar Now Available in the U.S.

by Joy Lin
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Amgen’s Amjevita, a biosimilar to Humira (adalimumab), is now available in the U.S., said the American company. Amjevita was the first biosimilar to Humira approved by the U.S. FDA in September 2016. 

“With today’s announcement, AMJEVITA is the first U.S. biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. 

“With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs.”

Related Article: A Force To Be Reckoned With – BioBetter Biologics

55% Below Humira’s List Price

A 40 mg citrate-free formulation of Amjevita will be sold at a wholesale acquisition cost 55% below that of the current Humira; the biosimilar will be available at a list price 5% below that of the current Humira. The drug will be offered in a prefilled syringe and an autoinjector. 

A high-concentration formulation of Humira is being tested in Phase 3 studies. According to Amgen, the US approval and launch for the high-concentration version are expected in 2024.  

Amjevita is approved to treat seven inflammatory diseases including:

  • moderate-to-severe rheumatoid arthritis in adults
  • moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
  • psoriatic arthritis in adults
  • ankylosing spondylitis in adults
  • moderate-to-severe chronic plaque psoriasis in adults
  • moderate-to-severe Crohn’s disease in adults and pediatric patients 6 years of age and older 
  • moderate-to-severe ulcerative colitis in adults. 

This constitutes all of the approved indications for Humira, with the exception of hidradenitis suppurativa. 

Humira Biosimilars See Delayed Launch In 2023

While first approved in 2016, the US launch of Amjevita has been delayed until now. The reason for this is because Abbvie, the drug developer of Humira, has sued every biosimilar manufacturer of Humira in patent infringement lawsuits. This has led to settlement agreements where the manufacturers would postpone their product launches until 2023. Besides Amjevita, nine other biosimilars are expected to launch in the US this year. 

Of all the biosimilar products referencing Humira, only Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has been approved as an interchangeable product to Humira. While Amgen’s Amjevita does not have an interchangeability, the company has begun a Phase 3 switching study in plaque psoriasis to support the approval for interchangeability.  

Outside the US, Amjevita is available in the European Union and Canada under the brand name Amgevita. 

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